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Phase II trial of gemcitabine in combination with cisplatin in inoperable or advanced hepatocellular carcinoma
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Chia, Whay Kuang, Ong, Simon, Toh, Han Chong, Hee, Siew Wan, Choo, Su Pin, Poon, Donald Y. H., Tay, Miah Hiang, Tan, Chee Kiat, Koo, Wen Hsin and Foo, Kian Fong (2008) Phase II trial of gemcitabine in combination with cisplatin in inoperable or advanced hepatocellular carcinoma. Annals of the Academy of Medicine, Singapore, 37 (7). pp. 554-558. ISSN 0304-4602 .
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Official URL: http://europepmc.org/abstract/MED/18695766
Abstract
Introduction: Advanced hepatocellular carcinoma (HCC) has a dismal prognosis and is
notoriously chemo-resistant. We conducted a Phase II prospective study to evaluate the activity
and tolerability of gemcitabine and cisplatin in chemo-naïve advanced hepatocellular carcinoma.
The trial considered a “no further interest” response rate of 10% and a target response rate of
30%. Utilising a Simon’s minimax two-stage design with a type I error of 0.05 and power of 80%,
25 subjects would be required. Fifteen patients would be needed in stage 1 and if fewer than 2
responses were observed, the trial would be stopped and lack of efficacy claimed. Materials and
Methods: Patients with advanced HCC, diagnosed based on histology or by World Health
Organization (WHO) criteria, were administered gemcitabine 1000 mg/m2
and cisplatin 25 mg/
m2
on day 1 and day 8 of a 21-day schedule. Assessment of response based on computer
tomography was performed after every 2 cycles of chemotherapy. Results: The trial was stopped
early due to a lack of efficacy. A total of 15 patients were accrued. Twelve patients were hepatitis
B positive and the other 3 patients were negative for both hepatitis B and C. Only 1 patient had
a history of prior heavy alcohol use. Two patients had Child C liver cirrhosis, 5 patients had Child
B cirrhosis, and the remaining 8 patients had Child A cirrhosis. This regime was well tolerated
and there was only 1 patient who experienced grade IV toxicities. Only 5 of 15 patients
experienced grade III toxicities (nausea and emesis, 1 patient; anemia, 1 patient; thrombocytopenia,
1 patient; and neutropaenia, 2 patients). Only 1 patient experienced a partial response to the
combination of gemcitabine and cisplatin. A further 3 patients experienced stable disease and 11
patients progressed on chemotherapy. The median time to progression was 6 weeks. The
progression-free curve showed a sharp descent in the initial part of the study, suggesting that
many patients had disease progression after enrolment. The median overall survival was 18
weeks. Conclusion: The progression-free survival and overall survival in our study were
extremely short. Based on the results of our phase 2 study, we are unable to recommend further
studies utilising gemcitabine and cisplatin combination in patients with advanced HCC
Item Type: | Journal Article | ||||
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Statistics and Epidemiology Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Journal or Publication Title: | Annals of the Academy of Medicine, Singapore | ||||
Publisher: | Academy of Medicine Singapore | ||||
ISSN: | 0304-4602 | ||||
Official Date: | 2008 | ||||
Dates: |
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Volume: | 37 | ||||
Number: | 7 | ||||
Page Range: | pp. 554-558 | ||||
Status: | Peer Reviewed | ||||
Publication Status: | Published | ||||
Access rights to Published version: | Restricted or Subscription Access |
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